MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Liver Laceration(s) (1955)

Event Date 06/14/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, a husband called zoll representative to report that his wife was resuscitated with the aid of an autopulse platform (b)(6), after suffering a massive pulmonary embolism (pe) 3 weeks post-partum.Unfortunately, his wife received severe lacerations to her liver because of the cardiopulmonary resuscitation cpr.According to the report, the husband had a conversation with the accident and emergency (a&e) doctor, and the doctor mentioned he had trouble in fitting the autopulse platform due to the size of patient breasts.Patient survived the pe and the internal bleeding, and suffered a stroke, which might have been prevented had she been able to receive the anticoagulants she required - a course of action which was prevented by the liver lacerations.Per reporter statement, performing cpr can carry a risk of internal injuries even correctly administered.But given the severity of the wife injuries and the confession of the doctor, the husband strongly suspect that the liver lacerations have occurred because of malpractice, rather than an unavoidable by product of the device itself.No further details provided.

Manufacturer Narrative

An autopulse platform was returned to zoll for evaluation due to a complaint about a patient received severe lacerations to her liver during the use of a zoll autopulse platform (b)(6)".During the investigation by zoll service technician, the autopulse platform passed the initial functional testing without any fault or error.Load cell characterization results confirmed both load cell modules function within the specification.No device malfunction during testing and it functioned as intended.No lifeband or battery return with the autopulse platform.During visual inspection, no physical damage was observed on the platform.Inspect and verify the drive train motor brake gap is within the specification of 0.008" ±0.001".Based on the archive review, no significant discrepancies were observed.There was no device active operation recorded on the reported event date.However, on june 28, the user activated "take-up" by pressing the start button and then aborted.The platform was tested with the large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.The autopulse has passed all the testing and meets all required specifications.The autopulse platform functioned appropriately and performed as intended.Chest compression, as a part of cardiopulmonary resuscitation (cpr), has a high rate of patient adverse events.Common internal organ injuries (liver and spleen), and common clinical events secondary to those injuries are expected adverse event for both manual and mechanical cprs.The chest compression generated by the autopulse system may lead to an injury profile that is no worse than manual cpr.Similarly, a randomized trial of manual cpr and phased manual plus autopulse cpr found no difference in cardiac, pulmonary, or cerebral damage.Complications in autopulse-treated patients occurred at a rate not exceeding that of manual cpr.The 2015 aha guidelines update for cpr reemphasized the importance of high-quality chest compressions and recommends ensuring adequate compression rates and adequate compression depth.Injuries due to chest compression are common but acceptable consequences of manual and mechanical cpr.Concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim is death.The event of liver laceration was serious because it was life-threatening, and it's possibly related to the autopulse device since the connection of the reported injury to using autopulse cannot be ruled out, and also possibly related to the procedure.

Event Description

A husband of a female patient called zoll representative on (b)(6) 2023, to report that his wife was resuscitated with the aid of an autopulse platform (sn: (b)(6) on (b)(6) 2022, after suffering a massive pulmonary embolism (pe) 3 weeks post-partum.Unfortunately, his wife received severe lacerations to her liver because of the cardiopulmonary resuscitation (cpr).The husband of the patient suspected that the lifeband was not positioned correctly.According to the report, the husband had a conversation with the accident and emergency (a&e) doctor afterwards, and the doctor had apologized for the damage caused during the cpr and mentioned that he had trouble in fitting the lifeband on the autopulse platform due to the size of patient breasts.The husband of the patient stated "patient survived the pe and the internal bleeding, and suffered a stroke, which might have been prevented had husband's wife been able to receive the anticoagulants she required - a course of action which was prevented by the liver lacerations.Per the husband of the patient statement, performing cpr can carry a risk of internal injuries even correctly administered.But given the severity of his wife's injuries and the confession of the doctor, the husband strongly suspects that the liver lacerations have occurred because of malpractice, rather than an unavoidable by product of the device itself.It is unknown if manual cpr was performed and no further information from the healthcare facility where the incident occurred.

Manufacturer Narrative

Corrections made on the device event or problem (b5), manufacturer narrative (h10) and updated in the type of investigation (h6).An autopulse platform was returned to zoll for evaluation due to a complaint about a patient received severe lacerations to her liver during the use of a zoll autopulse platform (sn: (b)(6)".During the investigation, the autopulse platform passed the initial functional testing without any fault or error.Load cell characterization results confirmed both load cell modules function within the specification.No device malfunction during testing and it functioned as intended.No return of a lifeband or a battery with the autopulse platform.During visual inspection, no physical damage was observed on the platform.Inspect and verify the drive train motor brake gap is within the specification of 0.008" ±0.001".The platform was tested with the large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.The autopulse has passed all the testing and meets all required specifications.The autopulse platform functioned appropriately and performed as intended.Chest compression, as a part of cardiopulmonary resuscitation (cpr), has a high rate of patient adverse events.Common internal organ injuries (liver and spleen), and common clinical events secondary to those injuries are expected adverse event for both manual and mechanical cprs.The chest compression generated by the autopulse system may lead to an injury profile that is no worse than manual cpr.Similarly, a randomized trial of manual cpr and phased manual plus autopulse cpr found no difference in cardiac, pulmonary, or cerebral damage.Complications in autopulse-treated patients occurred at a rate not exceeding that of manual cpr.The 2015 aha guidelines update for cpr reemphasized the importance of high-quality chest compressions and recommends ensuring adequate compression rates and adequate compression depth.Injuries due to chest compression are common but acceptable consequences of manual and mechanical cpr.Concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim is death.The event of liver laceration was serious because it was life-threatening, and it's possibly related to the autopulse device since the connection of the reported injury to using autopulse cannot be ruled out, and also possibly related to the procedure.

• Brand Name: AUTOPULSE RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim nguyen ; 2000 ringwood ave; san jose, CA 95131
• MDR Report Key: 17657647
• MDR Text Key: 322362070
• Report Number: 3010617000-2023-00745
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female