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

Model Number MODEL 100

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

Patient Problem Paraplegia (2448)

Event Date 05/28/2023

Event Type  Injury  

Manufacturer Narrative

Zoll has not yet received the autopulse platform in the complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.Event of paraplegia was assessed as serious, event resulted in persistent or significant disability or incapacity.Event assessed as possibly related to the autopulse platform and possibly related to the procedure.Paraplegia is an unanticipated event.The spinal infarcts may be related manual cpr.

Event Description

The autopulse platform (sn (b)(6)) was used on a 76 year old, 102 kg male patient who was coded for a total of 40 minutes.The patient has a history of anemia, a-fib, cad, chf, ckd, copd, colon polyps, diabetes, diabetic neuropathy, gastroparesis, gerd, hyperlipidemia, htn, obesity, pvd, and sleep apnea.The patient was taking acetadote, albuterol, amiodarone, eliquis, lipitor, dulcolax, plavix, digoxin, flonase, lantus, humalog, metoprolol, protonix, zosyn, mirilax, and lyrica.The cardiac arrest was witnessed in-patient, and the patient received manual cpr for approximately 15 minutes, prior to being placed on the platform.The platform was used for the rest of the call without any issues or malfunction.Return of spontaneous circulation (rosc) was successfully achieved, and the patient has full neurological function.However, the patient has a new development of paraplegia and is unable to walk.This symptom was noticed several hours after the event.An mri was performed and confirmed several spinal infarcts.There was a question of this being caused by the platform.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 17239683
• MDR Text Key: 318224575
• Report Number: 3010617000-2023-00558
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 76 YR
• Patient Sex: Male
• Patient Weight: 102 KG