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

Model Number MODEL 100

Device Problems Electrical /Electronic Property Problem (1198); Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2019

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn (b)(4)) powered off on its own for 3 times" was confirmed during the archive data review but not during the initial functional testing.There were no device deficiencies found during the evaluation of the platform, which could have caused or contributed to the reported event.The root cause was undetermined due to unable to reproduce the customer complaint during evaluation.Upon visual inspection, no physical damage was observed.The platform passed initial functional testing without any fault or error.Review of the archive data showed occurrence of under voltage <18v uncommand shut off for three times on the reported event date.On 05/04/2019, autopulse li-ion battery (sn (b)(4)) was inserted.While sizing the patient (take-up), the autopulse has detected that the patient's chest was too stiff to compress and then the device shut off.A different autopulse li-ion battery (sn (b)(4)) was inserted.The platform powered on and performed two sessions, 169 compressions and 8 compressions and then experienced user advisory (ua) 17 (max motor on time exceeded) message and then shut off.The platform was powered on again and then shut off one more time while sizing the patient (take-up).A drive train motor brake gap inspection was performed and verified the gap was within the specification of 0.008" ±0.001".The load cell characterization test confirmed both load cell modules are functioning within the specification.A run-in test was performed using the 95% patient large resuscitation test fixture (lrtf) using known good test batteries until discharged without any fault or error.Replaced the pdb (power distribution board) as a precautionary measure to prevent the re occurrence of the reported complaint.User advisory is a clearable error message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.Ua17 is an indication that the lifeband is twisted or battery voltage is low.The recommended actions to take for this type of user advisory are: open lifeband, start manual cpr, check battery and lifeband, pull up completely on the lifeband, ensure that the patient and the band are properly aligned, and press restart.Following service, the autopulse platform passed the final testing without any error or fault.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse platform with sn (b)(4).

Event Description

During patient use, the autopulse platform (sn (b)(4)) powered off on its own for 3 times.The user tried to troubleshoot by inserting other autopulse li-ion batteries, however the platform continued to power off.Immediately, the crew reverted to manual cpr.No patient consequence was reported.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• Manufacturer Contact: kimthoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4085411030
• MDR Report Key: 8648141
• MDR Text Key: 146383458
• Report Number: 3010617000-2019-00438
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 05/15/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2017
• 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