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 Laceration(s) (1946)

Event Date 09/20/2022

Event Type  Injury  

Manufacturer Narrative

Zoll has received the autopulse platform (sn 24671) for investigation.A follow-up report will be submitted when the investigation has been completed.Chest compression, as a part of cardiopulmonary resuscitation (cpr), has a high rate of patient adverse events.Common injuries (skin, rib, sternum, and spine fracture), common internal organ injuries (liver and spleen), and common clinical events secondary to those injuries (pneumothorax) are expected adverse events 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 aha guidelines 2000 states, "even properly performed chest compressions can cause rib fractures in adult patients." the guidelines further state, "concern for injuries that may complicate cpr should not impede the prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death." the recently released guidelines 2005 deliver a similar message, "rib fractures and other injuries are common but acceptable consequences of cpr given the alternative of death from cardiac arrest." the 2015 aha guidelines update for cpr reemphasized the importance of high-quality chest compressions and recommends to ensure adequate compression rates and adequate compression depth.Rib fractures and other injuries are common but acceptable consequences of manual and mechanical cpr.Concern for injuries that may complicate cpr should not impede the prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death.Based on available information, the event of skin laceration was not serious since it didn't meet any criteria of seriousness per regulations.Due to the skin laceration location and the time point, the event of skin laceration was probably related to the autopulse device.The query for further details like the patient's weight, size, and concomitant medical condition was sent to the customer for clarification.Re-assessment will be made when further information is available.

Event Description

The customer reported that the lifeband (lot #unknown) caused a skin laceration on the patient's torso during the resuscitation using the autopulse platform (sn 24671).The customer provided no further information.Please see the following related mfr report: mfr 3010617000-2022-01858 for the lifeband (lot #unknown).

Manufacturer Narrative

The autopulse platform (sn (b)(6)) involved in the reported complaint event was returned to zoll for investigation.During the investigation, no device malfunction was observed, and the autopulse platform functioned as intended.The photo of the lifeband provided by the customer revealed torn lifeband belt cover.Based on the archive, the autopulse platform performed approximately 3 minutes of compression.It indicated no excessive weight on the autopulse platform, and there was no user advisory or a fault related to the torn lifeband.The customer provided no response to the follow-up questions.Therefore, the exact root cause of the torn lifeband was undetermined; however, user mishandling cannot be ruled out.During the installation of the lifeband by the customer, the lifeband belt cover would have potentially torn, exposing the lifeband band to be in direct contact with the patient's skin and could have resulted in skin laceration.Historical complaints were reviewed for "skin laceration" reported worldwide from november 2003 to november 2022, and this is the first reported incident of "skin laceration." therefore, the severity is minor, the probability of harm is improbable, and the risk level is low.Per autopulse system user guide, warning: failure to properly position the lifeband at the patient's armpit line may cause injury to the patient.Failure to properly position a patient, both vertically and laterally with respect to the platform, may cause injury to the patient.Upon visual inspection of the autopulse platform, no physical damage was observed.The autopulse platform passed the functional testing without fault or error, and the archive data indicated no significant discrepancies.Following service, the brake gap inspection was performed and verified the brake gap was within the specification.A load cell characterization test confirmed that both cell modules function within the specification.The autopulse platform passed the final run-in test without any fault or error.Chest compression, as a part of cardiopulmonary resuscitation (cpr), has a high rate of patient adverse events.Common injuries (skin, rib, sternum, and spine fracture), common internal organ injuries (liver and spleen), and common clinical events secondary to those injuries (pneumothorax) are expected adverse events 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 aha guidelines 2000 states, "even properly performed chest compressions can cause rib fractures in adult patients." the guidelines further state, "concern for injuries that may complicate cpr should not impede the prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death." the recently released guidelines 2005 deliver a similar message, "rib fractures and other injuries are common but acceptable consequences of cpr given the alternative of death from cardiac arrest.".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.Rib fractures and other injuries are common but acceptable consequences of manual and mechanical cpr.Concern for injuries that may complicate cpr should not impede the prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death.Based on available information, the event of skin laceration was not serious since it didn't meet any criteria of seriousness per regulations.Due to the skin laceration location and the time point, the event of skin laceration was probably related to the autopulse device.The query for further details like the patient's weight, size, and concomitant medical condition was sent to the customer for clarification.Re-assessment will be made when further information is available.

• 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 thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 15612905
• MDR Text Key: 301819021
• Report Number: 3010617000-2022-01857
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2022
• Initial Date FDA Received: 10/16/2022
• Supplement Dates Manufacturer Received: 10/25/2022
• Supplement Dates FDA Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2021
• 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